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Comments
During our technical validation phase of Flow cytometry, it was noted that the presence or absence of HLA-B*27 Ag could not be determined in 5 % of patients. This is linked to the high polymorphism of HLA System, without any pathological consequence.
In that case, in case of positive results, or if the sample has exceeded the preanalytical delay of 5 days which has been validated, it will be necessary to perform another technique, HLA-B*27 genotyping, allowing the search of presence or absence of HLA:B*27 allele.
In that case, additional documents will be necessary because this genotyping needs to respect the French Bioethics law (décret n° 2008-321 dated 2008, April 4th) requiring Prescriber's contact details and consultation attestation, together with the patient's informed consent.
The laboratory or our agent may provide such documents. These documents can be downloaded from Laboratoire Cerba web site (http://www.lab-cerba.com/files/live/sites/Cerba/files/documents/EN/CONSGB.pdf)
At reception by our Medical Secretariat (E-Mail: smexport@lab-cerba.com), of this fulfilled documents and the request of "HLA-B*27 genotyping", we will be able to use the original sample already in Laboratoire Cerba. This request must be done within 30 days. Beyond this time the patient must be recalled for a new sample.